21 CFR 514.105 - Approval of applications.

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There is 1 rule appearing in the Federal Register for 21 CFR Part 514. View below or at eCFR (GPOAccess)
§ 514.105 Approval of applications.
(a) The Commissioner shall forward for publication in the Federal Register a regulation prescribing the conditions under which the new animal drug may be used, including the name and address of the applicant; the conditions and indications for use covered by the application; any tolerance, withdrawal period, or other use restrictions; any tolerance required for the new animal drug substance or its metabolites in edible products of food-producing animals; and, if such new animal drug is intended for use in animal feed, appropriate purposes and conditions of use (including special labeling requirements) applicable to any animal feed; and such other information the Commissioner deems necessary to assure safe and effective use.
(b) He shall notify the applicant by sending him a copy of the proposed publication as described in paragraph (a)(1) of this section.
[40 FR 13825, Mar. 27, 1975, as amended at 51 FR 7392, Mar. 3, 1986; 64 FR 63203, Nov. 19, 1999]

Title 21 published on 2014-04-01.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-07-01; vol. 79 # 126 - Tuesday, July 1, 2014
    1. 79 FR 37175 - New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Direct final rule; confirmation of effective date.
      Effective date of final rule published in the Federal Register of March 17, 2014 (79 FR 14609) confirmed: July 30, 2014.
      21 CFR Part 514

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 514 after this date.

  • 2015-05-20; vol. 80 # 97 - Wednesday, May 20, 2015
    1. 80 FR 28863 - Antimicrobial Animal Drug Sales and Distribution Reporting
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule.
      Submit either electronic or written comments on the proposed rule by August 18, 2015. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by June 19, 2015 (see the “Paperwork Reduction Act of 1995” section of this document).
      21 CFR Part 514